Left bundle branch area pacing versus conventional right‑ventricular pacing after TAVI for atrioventricular block
Prospective Multicenter Randomized Controlled Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block
NA · Nantes University Hospital · NCT07236489
This will test whether left bundle branch area pacing works better than standard right‑ventricular pacing for people who need a pacemaker after TAVI.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 7 sites (Brest, Finistère and 6 other locations) |
| Trial ID | NCT07236489 on ClinicalTrials.gov |
What this trial studies
The study enrolls patients who develop atrioventricular block within three months after transcatheter aortic valve implantation and have preserved left ventricular ejection fraction. Participants meeting guideline indications for pacemaker implantation will receive either left bundle branch area pacing or conventional right‑ventricular pacemaker implantation at participating centers. Clinical and echocardiographic outcomes such as changes in LVEF, heart failure hospitalizations, and mortality will be compared during follow‑up. The intent is to see if physiological conduction via left bundle branch area pacing reduces pacing‑induced dyssynchrony and downstream complications compared with standard pacing.
Who should consider this trial
Good fit: Ideal candidates are patients within three months of TAVI who have preserved LVEF (≥50%) and a guideline indication for pacemaker implantation such as third‑degree AV block, Mobitz II or symptomatic Mobitz I block, alternating bundle branch block, HV interval ≥70 ms, or new/worsening conduction disturbances after TAVI.
Not a fit: Patients with LVEF below 50% before TAVI, those with a prior pacemaker, or those with contraindications to endocardial pacemaker implantation are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, this approach could better preserve normal ventricular activation, reduce heart failure events, and help maintain left ventricular function in patients needing pacemakers after TAVI.
How similar studies have performed: Retrospective and observational studies have suggested clinical and physiological benefits of left bundle branch area pacing, but prospective randomized evidence is limited or lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have undergone TAVI for severe aortic valve disease within the past 3 months * Preserved left ventricular ejection fraction (LVEF ≥ 50%) * Indications for pacemaker implantation according to guidelines, including : * Third-degree atrioventricular (AV) block * Second-degree AV block Mobitz type 2 or symptomatic Mobitz type 1 * Alternating left and right bundle branch block * HV interval ≥ 70 ms during electrophysiological study * Pre-existing right bundle branch block with worsening conduction disturbances post-TAVI * Prolongation of QRS and PR intervals post-procedure justifying pacemaker implantation * Signed informed consent * Patient affiliated with the national health insurance system Exclusion Criteria: * Left ventricular ejection fraction (LVEF) \< 50% before TAVI * Contraindication to implantation of an endocardial pacemaker (vascular access issues, sepsis) * Previously implanted pacemaker * Patients under legal guardianship, curatorship, or judicial protection * Participation in another interventional therapeutic clinical trial
Where this trial is running
Brest, Finistère and 6 other locations
- Brest University Hospital — Brest, Finistère, France (RECRUITING)
- Rennes University Hospital — Rennes, Ille-et-Vilaine, France (RECRUITING)
- Tours University Hospital — Tours, Indre-et-Loire, France (RECRUITING)
- Nantes University Hospital — Nantes, Loire-Atlantique, France (RECRUITING)
- Clermont Ferrand University Hospital — Clermont-Ferrand, Puy-de-Dôme, France (NOT_YET_RECRUITING)
- Rouen University Hospital — Rouen, Seine-Maritime, France (RECRUITING)
- Poitiers University Hospital — Poitiers, Vienne, France (RECRUITING)
Study contacts
- Study coordinator: Research and Innovation Departement of Nantes UH
- Email: bp-prom-regl@chu-nantes.fr
- Phone: +33253482810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrioventricular Block, Pacemaker, Atrioventricular block, TAVI, LBAP